Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy

对患有镰状细胞痛的青少年和新兴成年人的同伴支持：促进认知行为治疗的参与

• 批准号: 10745058
• 负责人: Alicia Colvin
• 金额: $ 81.92万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-10 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10745058
• 关键词: Address; Adolescent; Adolescent and Young Adult; Adult; Advocate; Age; Anxiety; Behavioral; Black race; Caring; Chronic; Clinical; Cognitive; Cognitive Therapy; Communities; Data; Development; Disparity; E-learning; Education; Educational process of instructing; Effectiveness; Emergency department visit; Empathy; Enrollment; Exercise; Exposure to; Family member; Focus Groups; Future; General Population; Healthcare Systems; Hospitalization; Individual; Infrastructure; Intervention; Learning Skill; Libraries; Mental Depression; Mental Health; Minority Groups; Moods; Multicenter Trials; National Center for Advancing Translational Sciences; Opioid; Outcome; Pain; Pain intensity; Pain interference; Pain management; Parents; Participant; Patients; Persons; Phase; Population; Provider; Randomized; Randomized, Controlled Trials; Reporting; Research Design; Resources; Running; Secondary pain; Secure; Sickle Cell; Sickle Cell Anemia; Site; Stress; Symptoms; Technology; Testing; Text; Therapeutic Intervention; Therapy trial; Training; Voice; Work; adolescent health outcomes; behavioral health; chronic pain; clinical research site; community organizations; community partnership; compare effectiveness; coping; cost; daily pain; design; diaries; digital; digital intervention; digital treatment; effectiveness evaluation; emerging adult; evidence base; experience; handheld mobile device; healing; health care service utilization; human centered design; implicit bias; improved; innovation; internalized stigma; meetings; non-opioid analgesic; opioid use; pain outcome; pain reduction; pain symptom; patient engagement; peer; peer coaching; peer support; personalized approach; personalized learning; preference; prescription opioid; primary outcome; programs; psychologic; psychological outcomes; psychological symptom; psychosocial; racial bias; randomized trial; secondary outcome; social stigma; stressor; support network; telephone based; treatment as usual; treatment group; uptake; video chat; virtual delivery

Abstract. Pain is the clinical hallmark of sickle cell disease (SCD), yet pain management remains inadequate for many in this population due to lack of evidence-based pain treatment approaches for SCD, and due to stigma and implicit bias in the healthcare system. Black adolescents and young adults (AYAs, ages 16-30) with SCD are particularly vulnerable as they endure repeat hospitalizations due to pain crises while coping with stigma and related stressors, as well as the other challenges of transitioning to adulthood. Opioids are the primary agent used in chronic SCD pain management, despite evidence that they provide poor long-term relief and lead to negative physical and psychological consequences. Psychosocial interventions that teach cognitive and behavioral strategies can simultaneously reduce pain and stigma and enhance mood in patients with SCD. Cognitive behavioral therapy (CBT) is the primary behavioral health approach to managing pain in the general population, and digital CBT has expanded its accessibility. In SCD and other minority populations, we have demonstrated that a low-cost, scalable, technology-delivered version of CBT is feasible and can be effective for addressing stress and pain. We have learned that personalized support can improve engagement with digital CBT. We will now test a personalized approach customized for AYAs with SCD using peer support delivered through community-based organizations (CBOs). We will conduct a multisite, randomized controlled trial of digital CBT to understand the level of support needed to achieve benefits for reducing pain and stigma. Our Peer suppoRt for adolescents and Emerging adults with Sickle cell pain: promoting ENgagement in Cognitive behavioral thErapy (PRESENCE) study aims to reduce pain, opioid use, and healthcare utilization among AYAs with SCD. During the UG3 phase, we will leverage an established infrastructure for delivering virtual peer support interventions, existing digital CBT programs tailored by and for people with SCD, and partnerships with CBOs to jointly refine the study design, digital CBT content, and peer support component and work with the HEAL ERN CCC and DCC to prepare for the UH3 trial. After meeting UG3 milestones and transitioning to the UH3 phase, we will randomize 470 AYAs with frequent pain (³4 days/wk) over the past ³3 months to one of 3 treatment groups: 1) a digital CBT program with weekly one-on-one peer support provided via text and/or telephone based on participant preference (CBT+peer), 2) the same digital CBT program without peer support (self-guided CBT), or 3) usual care (UC). We first hypothesize that AYAs receiving either digital CBT treatment (CBT+ peer or self-guided CBT) will have better pain and mental health outcomes than AYAs receiving UC at 6 months. Second, we hypothesize that CBT+peer will be associated with improved program engagement and pain and mental health outcomes at 6 months compared with self-guided CBT. The PRESENCE trial will determine effectiveness of digital CBT for pain management among AYAs with SCD, a critical step toward future wide-scale deployment as part of routine SCD care.

摘要：疼痛是镰状细胞病（SCD）的临床标志，但疼痛管理仍然不足。 对于这一人群中的许多人来说，由于缺乏基于证据的 SCD 疼痛治疗方法，并且由于 医疗保健系统中的耻辱和隐性偏见。 SCD 特别容易受到伤害，因为他们在应对各种疾病的同时还要忍受因疼痛危机而反复住院的情况 耻辱和相关的压力源，以及过渡到成年期的其他挑战是阿片类药物。 慢性 SCD 疼痛治疗中使用的主要药物，尽管有证据表明它们提供的长期缓解效果较差 并导致负面的身体和心理后果，教授认知能力。 行为策略可以同时减轻 SCD 患者的疼痛和耻辱并改善情绪。 认知行为疗法（CBT）是一般情况下控制疼痛的主要行为健康方法 人口，数字 CBT 已扩大了在 SCD 和其他少数群体中的可及性。 证明低成本、可扩展、技术交付的 CBT 版本是可行且有效的 我们了解到，个性化支持可以提高人们的参与度。 我们现在将使用同行支持来测试为 AYA 定制的个性化方法和 SCD。 我们将通过社区组织 (CBO) 进行多地点、随机控制的研究。 进行数字 CBT 试验，以了解实现减轻疼痛和耻辱感所需的支持水平。 我们为患有镰状细胞痛的青少年和新兴成年人提供同伴支持：促进参与 认知行为疗法 (PRESENCE) 研究旨在减少疼痛、阿片类药物的使用和医疗保健的利用 在 UG3 阶段，我们将利用已建立的基础设施进行交付。 虚拟同伴支持干预措施、由 SCD 患者量身定制的现有数字 CBT 计划，以及 与 CBO 合作，共同完善研究设计、数字 CBT 内容和同行支持组件， 在达到 UG3 里程碑和之后，与 HEAL ERN CCC 和 DCC 合作准备 UH3 试验。 过渡到 UH3 阶段，我们将随机分配 470 名在过去频繁疼痛（³4 天/周）的 AYAs ³3 3 个治疗组之一为期数月：1) 数字 CBT 计划，每周提供一对一同伴支持 根据参与者偏好（CBT+同伴）通过短信和/或电话，2) 相同的数字 CBT 计划 没有同伴支持（自我引导 CBT），或 3）常规护理（UC） 我们首先发现 AYA 正在接受其中一种治疗。 数字 CBT 治疗（CBT+同伴或自我引导 CBT）将比数字化 CBT 治疗带来更好的疼痛和心理健康结果 其次，我们认为 CBT+peer 将与改善相关。 与自我引导 CBT 相比，项目参与度以及 6 个月时的疼痛和心理健康结果。 PRESENCE 试验将确定数字 CBT 对患有 SCD 的 AYA 进行疼痛管理的有效性。 作为日常 SCD 护理的一部分，这是迈向未来大规模部署的关键一步。